MD4622B1 - Minigranules for sustained release of trimetazidine - Google Patents
Minigranules for sustained release of trimetazidineInfo
- Publication number
- MD4622B1 MD4622B1 MDA20130005A MD20130005A MD4622B1 MD 4622 B1 MD4622 B1 MD 4622B1 MD A20130005 A MDA20130005 A MD A20130005A MD 20130005 A MD20130005 A MD 20130005A MD 4622 B1 MD4622 B1 MD 4622B1
- Authority
- MD
- Moldova
- Prior art keywords
- trimetazidine
- minigranules
- sustained release
- plasma concentration
- treatment
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/16—Otologicals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/08—Vasodilators for multiple indications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Urology & Nephrology (AREA)
- Ophthalmology & Optometry (AREA)
- Otolaryngology (AREA)
- Vascular Medicine (AREA)
- Hospice & Palliative Care (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention relates to pharmaceutics, namely to minigranules for sustained release of trimetazidine, wherein an inner phase comprises trimetazidine dihydrochloride deposited on a neutral core and a binder, and an outer layer comprises a retardant, an anti-agglomerant and a plasticiser.The minigranules, according to the present invention, provides a gradual and sustained release of trimetazidine over 24 hours at a therapeutic efficacious plasma concentration and an availability of trimetazidine at a therapeutic efficacious plasma concentration following the administration.The invention also described a process for manufacture of minigranules and use thereof in the prophylactic treatment of angina pectoris, in the course of chorioretinal disorders and also in the treatment of vertigo of vascular origin.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR1200322A FR2986431B1 (en) | 2012-02-03 | 2012-02-03 | PROLONGED RELEASE OF TRIMETAZIDINE PHARMACEUTICAL COMPOSITION, PROCESS FOR THE PRODUCTION THEREOF AND USE IN THERAPEUTIC TREATMENTS |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| MD20130005A2 MD20130005A2 (en) | 2013-07-31 |
| MD4622B1 true MD4622B1 (en) | 2019-03-31 |
| MD4622C1 MD4622C1 (en) | 2019-10-31 |
Family
ID=47504206
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MD20130005A MD4622C1 (en) | 2012-02-03 | 2013-02-03 | Minigranules for sustained release of trimetazidine |
Country Status (47)
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP6254719B2 (en) * | 2014-04-08 | 2017-12-27 | ダウ グローバル テクノロジーズ エルエルシー | Dispersion containing esterified cellulose ether |
| WO2018094387A1 (en) * | 2016-11-21 | 2018-05-24 | Saghmos Therapeutics, Inc. | Prevention and/or treatment of contrast-induced acute kidney injury |
| CN109316455B (en) * | 2017-07-31 | 2021-05-25 | 北京福元医药股份有限公司 | Trimetazidine hydrochloride sustained release tablet |
| CN110237053A (en) * | 2019-07-26 | 2019-09-17 | 湖北欣泽霏药业有限公司 | A kind of trimetazidine hydrochloride sustained-release pellet and preparation method thereof |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NL270408A (en) * | 1960-10-20 | |||
| FR2490963B1 (en) | 1980-09-30 | 1986-04-18 | Science Union & Cie | NOVEL THERAPEUTIC COMPOSITION WITH ANTI-ISCHEMIC ACTION CONTAINING TRIMETHOXY 2, 3, 4-BENZYL 1-PIPERAZINE |
| JPH04169522A (en) * | 1990-11-01 | 1992-06-17 | Shin Etsu Chem Co Ltd | Sustained release tablet and preparation thereof |
| FR2717687B1 (en) * | 1994-03-24 | 1996-06-14 | Adir | Pharmaceutical compositions for the sustained release of trimetazidine after oral administration. |
| FR2802424B1 (en) * | 1999-12-17 | 2002-02-15 | Adir | MATRIX TABLET FOR THE EXTENDED RELEASE OF TRIMETAZIDINE AFTER ORAL ADMINISTRATION |
| PT1195160E (en) * | 2000-10-05 | 2009-12-07 | Usv Ltd | Sustained release trimetazidine pharmaceutical compositions and a method of their preparation |
| HUP0500382A3 (en) * | 2001-11-21 | 2008-03-28 | Themis Lab Private Ltd | Sustained release pharmaceutical compositions containing microbeads of trimetazidine dihydrochloride and process for producing them |
| RU2281772C1 (en) * | 2005-02-14 | 2006-08-20 | Закрытое акционерное общество "Фармацевтическое предприятие "Оболенское" | Medicinal formulation possessing anti-anginal effect and method for its preparing |
| EP2020995A2 (en) * | 2006-05-09 | 2009-02-11 | Mallinckrodt Inc. | Zero-order modified release solid dosage forms |
| CN100571703C (en) * | 2006-12-20 | 2009-12-23 | 山东省医药工业研究所 | Sustained-release micro-pellet of trimetazidine and preparation method thereof |
| CN104739819A (en) * | 2007-11-09 | 2015-07-01 | 田边三菱制药株式会社 | Novel Preparation |
| RU2362548C1 (en) * | 2007-11-20 | 2009-07-27 | Закрытое Акционерное Общество "Канонфарма Продакшн" | Matrix tablet with basis for trimetazidine dihydrochloride release, way of its reception and way of treatment |
| WO2010084397A2 (en) * | 2009-01-20 | 2010-07-29 | Micro Labs Limited | Modified release solid pharmaceutical compositions of trimetazidine and process thereof |
| EP2391353B1 (en) * | 2009-01-30 | 2016-02-10 | Lupin Limited | Pharmaceutical compositions of trimetazidine |
| EP2408437A1 (en) * | 2009-03-18 | 2012-01-25 | Evonik Röhm GmbH | Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising a polymer mixture and excipients |
| ES2508490T3 (en) * | 2010-05-04 | 2014-10-16 | Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi | Formulation of trimetazidine with different release profiles |
| CN102133195A (en) * | 2011-03-17 | 2011-07-27 | 王国栋 | Trimetazidine dihydrochloride sustained control release pellet and preparation method thereof |
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2012
- 2012-02-03 FR FR1200322A patent/FR2986431B1/en not_active Expired - Fee Related
- 2012-05-09 RO ROA201200317A patent/RO128004A3/en unknown
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2013
- 2013-01-23 PH PH12013000031A patent/PH12013000031B1/en unknown
- 2013-01-24 PE PE2013000132A patent/PE20131119A1/en active IP Right Grant
- 2013-01-25 SG SG2013006119A patent/SG192386A1/en unknown
- 2013-01-25 UY UY0001034595A patent/UY34595A/en not_active Application Discontinuation
- 2013-01-27 JO JOP/2013/0029A patent/JO3505B1/en active
- 2013-01-28 MX MX2013001118A patent/MX363302B/en unknown
- 2013-01-28 AP AP2013006693A patent/AP2013006693A0/en unknown
- 2013-01-28 CU CU20130016A patent/CU24157B1/en active IP Right Grant
- 2013-01-28 CA CA2805471A patent/CA2805471C/en active Active
- 2013-01-28 CR CR20130037A patent/CR20130037A/en unknown
- 2013-01-29 US US13/753,313 patent/US10117838B2/en active Active
- 2013-01-29 GE GEAP201312984A patent/GEP20156342B/en unknown
- 2013-01-30 AU AU2013200481A patent/AU2013200481B2/en active Active
- 2013-01-30 HR HRP20130082AA patent/HRP20130082A2/en not_active Application Discontinuation
- 2013-01-30 IL IL224495A patent/IL224495B/en active IP Right Grant
- 2013-01-30 SV SV2013004396A patent/SV2013004396A/en unknown
- 2013-01-31 NI NI201300014A patent/NI201300014A/en unknown
- 2013-01-31 MY MYPI2013700179A patent/MY162599A/en unknown
- 2013-01-31 DO DO2013000024A patent/DOP2013000024A/en unknown
- 2013-01-31 UA UAA201301194A patent/UA118742C2/en unknown
- 2013-01-31 RS RS20130034A patent/RS20130034A1/en unknown
- 2013-01-31 GT GT201300032A patent/GT201300032A/en unknown
- 2013-01-31 CO CO13017769A patent/CO6720159A1/en unknown
- 2013-02-01 AR ARP130100294A patent/AR089861A1/en not_active Application Discontinuation
- 2013-02-01 EC ECSP13012415 patent/ECSP13012415A/en unknown
- 2013-02-01 SI SI201331428T patent/SI2623096T1/en unknown
- 2013-02-01 HU HUE13153638A patent/HUE043942T2/en unknown
- 2013-02-01 BR BR102013002524A patent/BR102013002524B1/en active IP Right Grant
- 2013-02-01 WO PCT/FR2013/050213 patent/WO2013114053A2/en active Application Filing
- 2013-02-01 TR TR2019/06390T patent/TR201906390T4/en unknown
- 2013-02-01 JP JP2013018173A patent/JP6338818B2/en active Active
- 2013-02-01 CL CL2013000336A patent/CL2013000336A1/en unknown
- 2013-02-01 EP EP13153638.5A patent/EP2623096B1/en active Active
- 2013-02-01 DK DK13153638.5T patent/DK2623096T3/en active
- 2013-02-01 PL PL13153638T patent/PL2623096T3/en unknown
- 2013-02-01 TW TW102104128A patent/TWI508755B/en active
- 2013-02-01 KR KR1020130011816A patent/KR20130090365A/en active Application Filing
- 2013-02-01 LT LTEP13153638.5T patent/LT2623096T/en unknown
- 2013-02-01 RS RS20190598A patent/RS58752B1/en unknown
- 2013-02-01 PT PT13153638T patent/PT2623096T/en unknown
- 2013-02-01 RU RU2013104252A patent/RU2621128C2/en active
- 2013-02-01 ES ES13153638T patent/ES2735053T3/en active Active
- 2013-02-01 EA EA201300079A patent/EA030227B1/en unknown
- 2013-02-03 MD MD20130005A patent/MD4622C1/en active IP Right Grant
- 2013-02-04 CN CN2013100434345A patent/CN103239425A/en active Pending
- 2013-02-04 CN CN201611094283.6A patent/CN106924221A/en active Pending
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2015
- 2015-08-26 KR KR1020150120470A patent/KR101918211B1/en active IP Right Grant
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2019
- 2019-06-14 HR HRP20191072 patent/HRP20191072T1/en unknown
- 2019-06-18 CY CY20191100621T patent/CY1121696T1/en unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG4A | Patent for invention issued |